Bioequivalence Study of Troxipide Tablet Formulations

Abstract

Troxipide is a novel gastro protective agent with antiulcer, anti-inflammatory and mucus secreting properties. This bioequivalence study was carried out to determine the pharmacokinetic profile of troxipide in plasma in an open label, comparative, randomized, two way cross over design involving two treatments and two periods with one week washout period in 28 healthy male subjects.Blood samples were collected at intervals up to 28 hours, as per the approved protocol. Plasma concentrations of troxipide were analyzed by high performance liquid chromatography (HPLC) and noncompartmental method was used for pharmacokinetic analysis. .10 h). There were no statistically significant differences between C max , AUC (0-t) and AUC (0-∞) and their log transformed data (p>0.05) for the test and reference formulations. The 90% of confidence intervals (C.I.s) for the test/reference ratio of mean C max , AUC (0-t) , and AUC (0-∞) were within the acceptable range of 80.00 to 125.00. The mean (±S.D.) times to maximal plasma concentration (t max ) of troxipide were 3.04±0.93 vs. 3.07±1.39 h for the test and the reference formulations respectively. Both the formulations were well tolerated.In conclusion, the two formulations were bioequivalent and may be used interchangeably.

An Open-Label, Multicenter Post Marketing Study to Assess the Symptomatic Efficacy and Safety of Troxipide [TroxipTM] in the Management of Acid Peptic Disorders in Indian Patients

“…Thus, even 3 hrs after attaining peak serum levels, Troxipide is found in therapeutically active concentrations in the small intestine, liver and stomach. It has a half life of 7.615±0.3782 hrs, and is mainly excreted in the urine (96%) as metabolites (61% after 24hrs and 87% after 48hrs) [11,26].…”